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Clinical Trial Summary

This project will pilot test a step-by-step guide developed by CDC for organizations to engage in evidence-based adaptation of interventions previously shown to be effective in research settings for use in real world applications. The second purpose of the program is to evaluate the adapted intervention to determine if it is effective in changing behavior of HIV+ African American men who have sex with other men.


Clinical Trial Description

During the ADAPT project both sites will adapt the original Community Promise intervention to specifically address the HIV prevention needs of sero-positive, African American men who have sex with men (HIV+ AAMSM) in either Boston, MA or Minneapolis/St. Paul (MSP), MN. The adapted intervention will be referred to as Community PROMISE, Positives Leading and Utilizing Strategies (CP PLUS).

In the first two months of the ADAPT project, the Boston and MSP sites will conduct formative evaluation activities (i.e., a comprehensive literature review, focus groups, and individual interviews) to assess the needs of the target population and organizational capacities to serve them. Results will be used to inform the adaptation of the original intervention to ensure that CP PLUS meet the expressed needs of the target population.

Process data will also be collected from various sources throughout the life of the project. Process data will be collected through staff meetings, interviews with staff, focus groups with peer advocates, and an expert panel consultation. Process data will be extremely useful for ensuring program objectives are met, improving CP PLUS, and providing information for providers in other locales who may be interested in adapting this intervention to serve this target population.

The Boston and MSP sites will also conduct outcome monitoring through collection of data concerning risk behaviors pre- and post-intervention implementation (follow-up at 6-8 months post and 11-13 months post [Boston only]) to determine if the adapted intervention has met its outcome objectives. Outcome monitoring will also be conducted for the "parent" intervention at both sites for HIV- or unknown status men who have sex with men.

In addition to the project activities, the organization will be examining the utility of the CDC draft guidance. The Boston and MSP sites are two of five case studies throughout the United States that will detail the challenges, successes and lessons learned from adapting an intervention packaged by CDC's Replicating Effective Programs (REP) and disseminated by Diffusing Effective Behavioral Interventions (DEBI) to a specific population. These findings will help other community-based organizations and Health Departments effectively adapt and tailor group, individual and community-level interventions. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00267436
Study type Interventional
Source Centers for Disease Control and Prevention
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 2006
Completion date February 2007

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